Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the … (NCT05986630) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face
Switzerland155 participantsStarted 2023-04-06
Plain-language summary
The clinical study is designed to prospectively evaluate the safety and effectiveness of TEOSYAL® TPVM when compared to COMPARATOR for the remodeling of the lower face
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy adult subjects over 18 years old seeking correction of their lower face
* Subject scored grade 2 or 3 on the TCRS
* Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
* Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
* Able to follow study instructions and complete all required visits.
* Having given its signed informed consent
Exclusion Criteria:
* Known hypersensitivity or previous allergic reaction to any component of the study devices
* Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
* History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
* Subject exhibits any physical attribute that may prevent assessment or treatment of the lower face as judged by the PI
* Clinically significant alcohol or drug abuse.
* Subject has received any investigational product within 90 days prior to Visit 1 or planning to participate in another investigation during the course of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is no longer recruiting, is there any chance I could still be considered for participation, or should we focus on other options for addressing my chin retrusion and lower face aging?
2This study is comparing TEOSYAL® TPVM to a comparator filler — can you explain what the comparator product is, and how the two differ in terms of what's currently known about their safety and effectiveness for chin retrusion?
3The main outcome being measured is a change in a chin retrusion score at 8 weeks after the last treatment — what does that timeline mean practically, and is 8 weeks considered a reliable window for judging how well a filler like this works?
4Since this trial doesn't have a traditional phase number, what does that tell us about how much safety and effectiveness data already exists for TEOSYAL® TPVM, and should that factor into my decision-making?
5Compared to just getting a standard dermal filler treatment for my chin outside of a trial, what are the potential advantages or trade-offs of being part of a study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator